Universal instrument guide for robotic surgical systems, surgical instrument systems, and methods of their use

ABSTRACT

Described herein are systems and apparatus of surgical instruments engineered for integration with robotic surgical systems to enhance precision in surgical procedures. Also described herein are methods of using such surgical instruments in performing surgical procedures. The use of such surgical instruments reduce complications arising from misalignment during surgery. The disclosed technology assists in stages of a surgical procedure that require a precise trajectory to be followed. Surgical instrument guides are attached to a universal surgical instrument guide, which is engineered to attach directly or indirectly with a robotic arm of a robotic surgical system. Surgical instruments can then be precisely guided along an axis defined by the universal surgical instrument guide. Individual instruments are easily inserted and removed from the channel of the universal surgical instrument guide, thus allowing a range of instruments to be used throughout a procedure while maintaining the surgical trajectory.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a non-provisional application which claims priorityto provisional application Ser. No. 62/447,733 filed on Jan. 18, 2017,which is incorporated in its entirety herein.

FIELD OF INVENTION

This invention relates generally to a universal instrument guide foruse, with a robotic surgical system, in guiding surgical instruments,surgical instrument systems for use with a universal instrument guide,and methods of their use.

BACKGROUND

Surgical procedures on the spine are generally complex proceduresinvolving many steps. When placing a pedicle screw in the vertebra, inaddition to the drilling stage, the tapping and screw placement (usingscrewdriver) stages are important for the success of the surgery. Forexample, in certain types of patients (e.g., having osteoporosis), evenin the case when the hole in the vertebra is precisely made, the bone isnot strong enough to guide other instruments and implants withoutadditional guidance from surgical instruments. This creates a hazardoussituation when surgeon assumes that he/she is guided by the drilled holewhile in reality the surgeon is placing instruments in other places(e.g., spinal canal) that can cause serious damages to the patient.

Robotic systems which provides assistance during only the drilling stageof a procedure have another potential disadvantage. In a clinicalsituation, the surface of a vertebra is covered by a multitude of softtissues. Even in open surgeries, when the surgeon has wide access to thespine, it is difficult to find the hole after it is drilled becausetissue often covers the entry point. In case of percutaneous surgeries,it is almost impossible due to lack of direct vision.

In order to overcome this difficulty, surgeons use a long wire, called a“k-wire,” which they place inside the drilled hole to mark it for lateruse. K-wires are used in a range of orthopedic surgeries. When drillingand placing a screw in a bone, surgeons use cannulated instruments(e.g., taps, screwdrivers) and implants (e.g., screws) so that all ofthem follow the wire such that they properly enter the drilled hole.

K-wires, even though widely used, have certain disadvantages. There is arisk that the k-wire advances with the guided instrument without thesurgeon realizing it. In certain cases, the k-wire can even go out of abone on the opposite side and hurt important tissues (e.g., aorta infront of the lumbar spine). In some cases, when the instrument advancesalong a different axis than the k-wire inside bone, the wire might bendand break or block the instrument inside the bone creating a verydifficult problem to resolve. There are known cases in which the k-wirecame loose and out of the bone without the surgeon realizing it. Thesurgeon followed this loose k-wire during the tapping and implantation(i.e., screw placement) stages which ultimately led to the screw beingplaced in a completely random place relative to the original drilledhole, thereby creating a hazard for the patient. At best, in thissituation a surgeon might realize that the k-wire is loose, however,upon realizing the k-wire is loose, the surgeon must drill a new holewhich might weaken the bone locally, for example, because now two holeswill be drilled in close to each other. Furthermore, redrillingunnecessarily prolongs the surgery. The likelihood of complications ink-wire use is significantly increased in percutaneous and minimallyinvasive surgeries (MIS) due to the obstructed view of the surgeon.

For these reasons spinal surgery is difficult to execute withoutcomplication. The use of a robotic surgical system to assist in precisebone drilling is of great use to a surgeon, but additional risks arisingfrom maintaining precise trajectories during tapping and implantplacement remain.

There is a need for surgical instruments and surgical instrument systemsengineered for use with robotic surgical systems that allow for precisetrajectories to be followed during all stages of surgical procedures.Particularly, surgical instruments engineered for use in drilling,tapping, and placing of implants are needed for use in orthopedic andspinal procedures, as well as neurological procedures.

SUMMARY

Described herein are systems and apparatus of surgical instrumentsengineered for integration with robotic surgical systems to enhanceprecision in surgical procedures. Also described herein are methods ofusing such surgical instruments in performing surgical procedures. Theuse of such surgical instruments reduce complications arising frommisalignment during surgery. Collectively a set of engineered surgicalinstruments as described herein (referred to herein collectively as “auniversal surgical instrument system”) assist in stages of a surgicalprocedure that require a precise trajectory to be followed. Surgicalinstrument guides are attached to a universal surgical instrument guide,which is engineered to attach directly or indirectly with a robotic armof a robotic surgical system. Surgical instruments can then be preciselyguided along an axis defined by the universal surgical instrument guide.In certain embodiments, the surgical trajectory is defined by an axisalong a channel in the universal surgical instrument guide. Individualinstruments are easily inserted and removed from the channel of theuniversal surgical instrument guide, thus allowing a range ofinstruments to be used throughout a procedure while maintaining thesurgical trajectory.

Universal surgical instrument guides provide an engineered interfacebetween a robotic arm and surgical instruments and their guides thateliminates the need for intraoperative realignment when switchingbetween instruments or instrument guides. Universal surgical instrumentguides are engineered to securely attach to a robotic arm usingalignment members (e.g., pins) that are received by openings in aportion of the robotic arm. The use of alignment members ensures theconsistent alignment of the universal surgical instrument guide relativeto the robotic arm. Universal surgical instrument guides have a channelfor holding surgical instrument guides and surgical instruments. Incertain embodiments, surgical instrument guides are inserted through achannel on a universal surgical instrument guide and are secured inplace by releasably attaching the surgical instrument guide to theuniversal surgical instrument guide. In certain embodiments, thesurgical instrument guide is releasably attached using threads on theuniversal surgical instrument guide and the surgical instrument guidethat engage each other. Universal surgical instrument guidesadditionally have an opening for attaching a navigation marker. Whencombined with patient measurements (e.g., CT data) taken pre- orintra-operatively, navigation markers enable surgeons to monitor theposition and trajectories of surgical instruments relative to apatient's anatomy intraoperatively with high precision.

The surgical instruments described herein may be used in conjunctionwith the universal surgical instrument guides described herein to assista surgeon in performing surgical procedures. Systems and apparatusdescribed herein may be used in orthopedic (e.g., spinal) surgicalprocedures to eliminate the need for a k-wire. Systems and apparatusdescribed herein may also be used with k-wires if desired or necessaryfor a given procedure. In certain embodiments, the systems and apparatusdescribed herein provide guidance of all important surgical instrumentsnecessary in methods of placing pedicle screws: a drill, a tap and ascrewdriver. In certain embodiments, systems and methods describedherein use an anti-skiving drill bit to ensure correct drilling even invery demanding anatomy.

In certain embodiments, sets of guides used in surgical procedures havea similar length such that a terminal end of each guide terminates insubstantially the same plane when each of the guides is inserted intothe universal surgical instrument guide. Thus, when tracking thelocation of surgical instruments during a procedure, the position of theterminal end of a guide can be used for intraoperative planning andtrajectory calculations by calculating the location of the terminal endbased on its engineered position relative to the universal surgicalinstrument guide (whose position is determined from the attachednavigation marker).

In certain embodiments, surgical methods comprise: trajectory planning,vertebrae approach, drilling, dilating, tapping, and screw placement.

In certain embodiments, trajectory planning is done using haptic,hands-on planning. No incision is necessary at this point as a surgeonuses a navigation system and a projected trajectory (e.g., based on theorientation of the universal surgical instrument guide and patientmeasurements from medical images and additional navigation markers) inorder to find an optimal entry point for the surgical procedure. Whenthe surgeon finds an optimal trajectory, the surgeon can block movementof the robotic arm on an axis defined by the orientation of the surgicalinstrument guide inserted in the universal surgical instrument guide.

In certain embodiments, to approach a bone, a surgeon makes a smallincision under the drill guide (after it is aligned using the roboticarm) and approaches the bone surface in a trajectory mode (e.g., thesurgical instrument guide and any surgical instrument place therethroughslides along a virtual line in space). In certain embodiments, thesurgeon has haptic feedback when going through various levels of softtissue and can feel when the instrument touches the bone. Hapticfeedback allows surgeon to confirm that the visual feedback the surgeonsees on a navigation screen is precise (e.g., if surgeon feels touchingthe bone and navigation shows that he is far away from it, it means thatthere is some navigation error). In certain embodiments, drilling isperformed using an anti-skiving drill bit.

In certain embodiments, dilators are used to provide clear access tosurgical sites while simultaneously facilitating surgical instrumentguidance. It is necessary to use dilators in percutaneous approaches inorder to protect soft tissue from destruction when tapping and screwplacement. Additionally, dilators can provide access channels wideenough for pedicle screw extenders.

In certain embodiments, tapping is performed using standard bone tapadapted to fit in an engineered surgical tap guide. Utilizing a roboticsurgical system to provide surgical tap guidance during this step isimportant for patient safety because a sharp tap could potentially takedifferent trajectory than drilled hole. In certain embodiments, a screwis placed together with a screw extender. A screw extender is necessaryin certain percutaneous procedures in order to later place a rod andperform reduction (i.e., re-alignment of spine).

The systems, apparatus, and methods described herein are particularbeneficial in percutaneous and MIS procedures, but can additionallyprovide benefit in open surgeries. Systems and apparatus describedherein enable surgeons to do percutaneous screw placement without usingk-wires. In certain embodiments, by guiding all instruments used in asurgical procedure, systems described herein simplify surgicalprocedures for surgeons as they are not required to find the sametrajectory several times (e.g., during planning, drilling, tapping andscrew placement). Additionally, potential risks are removed (e.g.,surgeon making an error and placing subsequent instruments in incorrecttrajectories) and surgery is potentially shortened.

In one aspect, the disclosed technology includes a universal surgicalinstrument guide for accommodating surgical instruments to facilitateprecise positioning of the surgical instruments using a robotic surgicalsystem, the universal surgical instrument guide including: a bodyarranged to be mechanically coupled to a robotic arm of the roboticsurgical system, the body comprising: a first channel comprising aninterior surface sized and shaped to accommodate a tightening screwthat, upon insertion and engaging of the tightening screw, securelyattaches the body directly or indirectly to the robotic arm of therobotic surgical system, a second channel (e.g., wherein a diameter ofthe second channel is greater than a diameter of the first channel)having an interior surface shaped and sized to accommodate a portion ofa surgical instrument guide, wherein: the second channel comprises afirst opening, wherein a portion of the second channel adjacent to thefirst opening is threaded such that when the surgical instrument guideis inserted in the second channel, threads of the threaded portion ofthe second channel engage threads on the surgical instrument guide tosecurely hold the surgical instrument guide, and the interior surface ofthe second channel defines an axis such that, when the surgicalinstrument guide is inserted into the universal surgical instrumentguide (e.g., when the threads of the threaded portion of the secondchannel engage the threads on the surgical instrument guide), movementof a surgical instrument is constrained along the axis when the surgicalinstrument guide is moved within the surgical instrument guide; and anopening (e.g., a threaded opening) sized and shaped to receive afastener to attach a navigation marker used by a navigation camera totrack the position of the surgical instrument guide; and one or morealignment members (e.g., 3 pins) extending from the body such that theone or more alignment members, upon mechanically coupling the body tothe robotic arm, engage one or more openings in the robotic arm (e.g., atool support of the robotic arm), thereby precisely locating theuniversal instrument guide relative to the robotic arm.

In certain embodiments, the body comprises an opening (e.g., fouropenings) (e.g., a threaded opening) sized and shaped to receive afastener to attach a handle support member (e.g., a rod) to the body(e.g., such that a sterile handle can be securely attached to the body).

In certain embodiments, the universal surgical instrument guide includesthe handle support member, wherein the handle support member is attachedto the body.

In certain embodiments, universal surgical instrument guide includes thenavigation marker attached to the body (e.g., wherein the navigationmarker comprising a plurality of navigation marker elements wherein theplurality of navigation marker elements are used to triangulate aposition of the universal surgical instrument guide).

In certain embodiments, the body comprises a threaded bushing having aninterior surface.

In certain embodiments, the interior surface of the threaded bushingdefines an axis parallel to an axis defined by the interior surface ofthe first channel and the interior surface of the threaded bushing isthreaded such that the threads on the tightening screw engage thethreads on the threaded bushing as the tightening screw is insertedthrough the threaded bushing.

In certain embodiments, the tightening screw includes: a tip on aproximate end of a screw body; a head on a distal end of the screw body;and threads along a portion of the screw body.

In certain embodiments, the threads along the portion of the screw bodyare along a portion of the screw body closest to the tip of thetightening screw.

In certain embodiments, the portion of the screw body closest to thehead is smooth such that the tightening screw is loosely held in placeby the threaded bushing when the tightening screw is fully inserted intothe threaded bushing.

In certain embodiments, the surgical instrument guide has a hollowtubular structure sized and shaped to receive a surgical instrumenttherethrough (e.g., the surgical instrument comprising a member selectedfrom the group consisting of: a drill bit, a tubular dilator, a roddilator, a surgical tap, a screw driver, a screw extender, and an awl).

In certain embodiments, the surgical instrument guide is a drill guide.

In certain embodiments, the surgical instrument is a drill bit and thedrill bit is an anti-skiving drill bit.

In certain embodiments, the surgical instrument guide is a master guide.

In certain embodiments, the robotic surgical system is for use in amember selected from the group consisting of: spinal surgery, ENTsurgery, neurosurgery, and orthopedic surgery.

In certain embodiments, an axis along a length of the first channel andan axis of along a length of the second channel are on a common plane.

In certain embodiments, the axis of along the length of the firstchannel and the axis along the length of the second channel are notperpendicular.

In certain embodiments, the axis along the length of the first channeland the axis along the length of the second channel are perpendicular.

In another aspect, the disclosed technology includes a universalsurgical instrument system for use in precise positioning and orientingof surgical instruments using a robotic surgical system, the universalsurgical instrument system including: a universal surgical instrumentguide comprising: a body arranged to be mechanically coupled to arobotic arm of the robotic surgical system, the body comprising: a firstchannel having an interior surface sized and shaped to accommodate atightening screw that, upon insertion and engaging of the tighteningscrew, securely attaches the body directly or indirectly to the roboticarm of the robotic surgical system, a second channel (e.g., wherein adiameter of the second channel is greater than a diameter of the firstchannel) having an interior surface shaped and sized to accommodate aportion of a surgical instrument guide, wherein: the second channelcomprises a first opening, wherein a portion of the second channeladjacent to the first opening is threaded such that when the surgicalinstrument guide is inserted in the second channel, threads of thethreaded portion of the second channel engage threads on the surgicalinstrument guide to securely hold the surgical instrument guide, and theinterior surface of the second channel defines an axis such that, whenthe surgical instrument guide is inserted into the universal surgicalinstrument guide (e.g., when the threads of the threaded portion of thesecond channel engage the threads on the surgical instrument guide),movement of a surgical instrument is constrained along the axis when thesurgical instrument guide is moved within the surgical instrument guide;an opening (e.g., four openings) (e.g., a threaded opening) sized andshaped to receive a fastener to attach a navigation marker used by anavigation camera to track the surgical instrument guide; and one ormore alignment members (e.g., 3 pins) extending from the body such thatthe one or more alignment members, upon mechanically coupling the bodyto the robotic arm, engage one or more openings in the robotic arm(e.g., a tool support of the robotic arm) thereby precisely locating theuniversal instrument guide relative to the robotic arm.

In certain embodiments, the universal surgical instrument systemincludes an opening (e.g., four openings) (e.g., at least one threadedopening) sized and shaped to receive a fastener to attach a handlesupport member (e.g., a rod) to the body (e.g., such that a sterilehandle can be securely attached to the body).

In certain embodiments, the universal surgical instrument systemincludes the handle support member, wherein the support member isattached to the body.

In certain embodiments, the body comprises an opening (e.g., fouropenings) (e.g., a threaded opening) sized and shaped to receive afastener to attach a handle support member (e.g., a rod) to the body(e.g., such that a sterile handle can be securely attached to the body).

In certain embodiments, the handle support member is attached to thebody.

In certain embodiments, the universal surgical instrument systemincludes the navigation marker attached to the body (e.g., wherein thenavigation marker comprising a plurality of navigation marker elementswherein the plurality of navigation marker elements are used totriangulate a position of the universal surgical instrument guide).

In certain embodiments, the body comprises a threaded bushing having aninterior surface.

In certain embodiments, the interior surface of the threaded bushingdefines an axis parallel to an axis defined by the interior surface ofthe first channel and the interior surface of the threaded bushing isthreaded such that the threads on the tightening screw engage thethreads on the threaded bushing as the tightening screw is insertedthrough the threaded bushing.

In certain embodiments, the tightening screw comprises: a tip on aproximate end of a screw body; a head on a distal end of the screw body;and threads along a portion of the screw body.

In certain embodiments, the threads along the portion of the screw bodyare along a portion of the screw body closest to the tip of thetightening screw.

In certain embodiments, the portion of the screw body closest to thehead is smooth such that the tightening screw is loosely held in placeby the threaded bushing when the tightening screw is fully inserted intothe threaded bushing.

In certain embodiments, universal surgical instrument system includesthe surgical instrument guide, wherein the surgical instrument guide hasa hollow tubular structure sized and shaped to receive a surgicalinstrument therethrough (e.g., the surgical instrument comprising amember selected from the group consisting of: a drill bit, a tubulardilator, a rod dilator, a surgical tap, a screw driver, a screwextender, and an awl).

In certain embodiments, the universal surgical instrument systemincludes the surgical instrument guide, wherein the surgical instrumentguide is a drill guide.

In certain embodiments, the universal surgical instrument systemincludes the surgical instrument, wherein the surgical instrument is adrill bit and the drill bit is an anti-skiving drill bit.

In certain embodiments, the surgical instrument guide is a master guide.

In certain embodiments, the robotic surgical system is for use in amember selected from the group consisting of: spinal surgery, ENTsurgery, neurosurgery, and orthopedic surgery.

In certain embodiments, an axis along a length of the first channel andan axis of along a length of the second channel are on a common plane.

In certain embodiments, the axis of along the length of the firstchannel and the axis along the length of the second channel are notperpendicular.

In certain embodiments, the axis along the length of the first channeland the axis along the length of the second channel are perpendicular.

In certain embodiments, the universal surgical instrument systemincludes a drill guide, the drill guide comprising: a proximal portioncomprising: a first exterior surface that is substantially in contactwith the interior surface of the second channel when the drill guide isaccommodated therethrough, a second exterior surface comprising threadsthat engage the threads of the threaded portion of the second channel tosecurely hold the drill guide when the drill guide is accommodatedtherethrough, and a collar adjacent to the first exterior surface,wherein a diameter of the collar is larger than a diameter of the firstexterior surface such that a distance the drill guide can be threadedthrough the second channel is limited by the collar; and a guiding shaftattached to the proximal portion, wherein the guiding shaft is sized andshaped to guide a drill bit therethrough along an axis defined by theinterior surface of the second channel to a surgical site.

In certain embodiments, the drill bit is an anti-skiving drill bit.

In certain embodiments, the guiding shaft of the drill guide iscylindrical.

In certain embodiments, the universal surgical instrument systemincludes a master guide, the master guide comprising: a proximal portioncomprising: a first exterior surface that is substantially in contactwith the interior surface of the second channel when the master guide isaccommodated therethrough, a second exterior surface comprising threadsthat engage the threads of the threaded portion of the second channel tosecurely hold the master guide when the master guide is accommodatedtherethrough, and a collar adjacent to the first exterior surface,wherein a diameter of the collar is larger than a diameter of the firstexterior surface such that a distance the master guide may be threadedthrough the second channel is limited by the collar, a guiding shaftattached to the proximal portion, wherein the guiding shaft has aninterior surface having a dimension such that a first surgicalinstrument or second surgical instrument guide can be accommodatedtherethrough along an axis defined by the interior surface of the secondchannel to a surgical site.

In certain embodiments, the guiding shaft of the master guide iscylindrical.

In certain embodiments, the proximal portion of the master guidecomprises: a first channel, wherein the first channel has an axiscoincident with an axis of the guiding shaft, and a first opening,wherein a portion of the first channel of the master guide adjacent tothe first opening is threaded such that when the second surgicalinstrument is accommodated therethrough, threads of the threaded portionof the first channel of the master guide engage threads on the secondsurgical instrument to securely hold the second surgical instrument.

In certain embodiments, the universal surgical instrument systemincludes a master guide (e.g., the master guide of any one of claims40-42), wherein the master guide has a length such that when the masterguide is fully threaded into the universal surgical instrument guide,the distance from the first opening of the universal surgical instrumentguide to a terminal end of the guiding shaft of the master guide is thedistance of a terminal end of the guiding shaft of the drill guide tothe first opening of the universal surgical instrument guide when thedrill guide is fully threaded into the universal surgical instrumentguide.

In certain embodiments, the universal surgical instrument systemincludes a tubular dilator, the tubular dilator comprising: a body witha cross-section such that the body can be accommodated within andthrough the guiding shaft of the master guide such that the tubulardilator is constrained to move only along an axis defined by the guidingshaft of the master guide, the body comprising: a guiding shaft havingan interior surface having a dimension such that a third surgicalinstrument can be accommodated therethrough along an axis defined by theinterior surface of the second channel to a surgical site.

In certain embodiments, the guiding shaft of the tubular dilator iscylindrical.

In certain embodiments, the guiding shaft has a tapered end.

In certain embodiments, the universal surgical instrument systemincludes a rod dilator, the rod dilator comprising: a body with across-section such that the body can be accommodated within and throughthe guiding shaft of the tubular dilator such that the rod dilator isconstrained to move only along the axis defined by the guiding shaft ofthe tubular dilator.

In certain embodiments, the universal surgical instrument systemincludes a surgical tap guide, the surgical tap guide comprising: aproximal portion comprising: an exterior surface comprising threads thatengage the threads of the threaded portion of the first channel of themaster guide to securely hold the surgical tap guide when the surgicaltap guide is accommodated therethrough, and a collar adjacent to thefirst exterior surface, wherein a diameter of the collar is larger thana diameter of the exterior surface of the surgical tap guide such that adistance the surgical tap guide may be threaded through the master guideis limited by the collar; and one or more stabilizing ends, each of theone or more stabilizing ends having: an exterior surface substantiallyin contact with the first channel of the master guide when the tap guideis accommodated therethrough, and an interior surface sized and shapedto guide a surgical tap along an axis defined by the interior surface ofthe second channel to a surgical site.

In certain embodiments, each of the one or more stabilizing ends of thesurgical tap guide is cylindrical.

In certain embodiments, the surgical tap guide has a length such thatwhen the surgical tap guide is fully threaded into the master guide, aterminal end of the surgical tap guide is approximately flush with aterminal end of the guiding shaft of the master guide.

In certain embodiments, the universal surgical instrument systemincludes a modified surgical tap, the modified surgical tap comprising:a body having an elongated member with homogeneous diameter; a proximalend comprising a handle sized and shaped for gripping by a surgeon; anda pointed, threaded distal end.

In certain embodiments, the universal surgical instrument systemincludes a screw extender having a body sized and shaped to be passthrough the guiding shaft of the master guide in a manner that isconstrained in all directions except a direction along the axis of thesecond channel, wherein the screw extender has an interior surface sizedand shaped to accommodate a portion of a screwdriver and a distal endfor releasably holding a surgical screw.

In certain embodiments, the universal surgical instrument systemincludes the surgical screw for placing in a bone of a patient, whereinthe surgical screw can be releasably held by the screw extender.

In certain embodiments, the universal surgical guide system includes ak-wire.

In another aspect, the disclosed technology includes a method of using arobotic surgical system, the method including the steps of: attaching auniversal surgical instrument guide to an end effector of a robotic arm,the universal surgical instrument guide arranged to securely hold asurgical instrument guide and restrict movement of a surgical instrumenttherethrough, wherein the universal surgical instrument guide comprises:a body comprising: a first channel comprising an interior surface sizedand shaped to accommodate a tightening screw that, upon insertion andengaging of the tightening screw, securely attaches the body directly orindirectly to the robotic arm of the robotic surgical system, a secondchannel (e.g., wherein a diameter of the second channel is greater thana diameter of the first channel) having an interior surface shaped andsized to accommodate a portion of a surgical instrument guide, whereinthe second channel comprises a first opening, wherein a portion of thesecond channel adjacent to the first opening is threaded such that whenthe surgical instrument guide is inserted in the second channel, threadsof the threaded portion of the second channel engage threads on thesurgical instrument guide to securely hold the surgical instrumentguide, and the interior surface of the second channel defines an axissuch that, when the surgical instrument guide is inserted into theuniversal surgical instrument guide (e.g., when the threads of thethreaded portion of the second channel engage the threads on thesurgical instrument guide), movement of a surgical instrument ins isconstrained along the axis when the surgical instrument guide is movedwithin the surgical instrument guide.

In certain embodiments, the body comprises a threaded bushing having aninterior surface.

In certain embodiments, the interior surface of the threaded bushingdefines an axis parallel to an axis defined by the interior surface ofthe first channel and the interior surface of the threaded bushing isthreaded such that the threads on the tightening screw engage thethreads on the threaded bushing as the tightening screw is insertedthrough the threaded bushing.

In certain embodiments, the tightening screw comprises: a tip on aproximate end of a screw body; a head on a distal end of the screw body;and threads along a portion of the screw body.

In certain embodiments, the threads along the portion of the screw bodyare along a portion of the screw body closest to the tip of thetightening screw.

In certain embodiments, the portion of the screw body closest to thehead is smooth such that the tightening screw is loosely held in placeby the threaded bushing when the tightening screw is fully inserted intothe threaded bushing.

In certain embodiments, attaching the universal surgical instrumentguide to an end effector of the robotic arm comprises: aligning theuniversal surgical instrument guide to the end effector, wherein theuniversal surgical instrument guide comprises one or more alignmentmembers (e.g., 3 pins) extending from the body such that the one or morealignment members, upon mechanically coupling the body to the roboticarm, engage one or more openings in the robotic arm (e.g., a toolsupport of the robotic arm) thereby precisely locating the universalinstrument guide relative to the robotic arm; and engaging thetightening screw.

In another aspect, the disclosed technology includes a robotic surgicalsystem for performing surgery, the system comprising: a robotic arm withan end effector comprising a universal surgical instrument guidearranged to securely hold a surgical instrument guide and restrictmovement of a surgical instrument therethrough; and a manipulatorarranged to allow robotically-assisted or unassisted positioning and/ormovement of the surgical instrument guide by a user with at least fourdegrees of freedom to align an axis defined by the universal surgicalinstrument guide at a desired trajectory in relation to a patientsituation, wherein the universal surgical instrument guide comprises: abody arranged to be mechanically coupled to the robotic arm, the bodycomprising: a first channel having an interior surface sized and shapedto accommodate a tightening screw that, upon insertion and engaging ofthe tightening screw, securely attaches the body directly or indirectlyto the robotic arm of the robotic surgical system, a second channel(e.g., wherein a diameter of the second channel is greater than adiameter of the first channel) having an interior surface shaped andsized to accommodate a portion of a surgical instrument guide, wherein:the second channel comprises a first opening, wherein a portion of thesecond channel adjacent to the first opening is threaded such that whenthe surgical instrument guide is inserted in the second channel, threadsof the threaded portion of the second channel engage threads on thesurgical instrument guide to securely hold the surgical instrumentguide, and the interior surface of the second channel defines an axissuch that, when the surgical instrument guide is inserted into theuniversal surgical instrument guide (e.g., when the threads of thethreaded portion of the second channel engage the threads on thesurgical instrument guide), movement of a surgical instrument guide isconstrained along the axis when the surgical instrument guide is movedwithin the surgical instrument guide, a handle support member (e.g., arod) arranged for the manipulator to be securely held thereto, and anopening (e.g., a threaded opening) sized and shaped to receive afastener to attach a navigation marker used by a navigation camera totrack the position of the surgical instrument guide.

In certain embodiments, the body comprises: an opening (e.g., fouropenings) (e.g., at least one threaded opening) sized and shaped toreceive a fastener to attach a handle support member (e.g., a rod) tothe body (e.g., such that a sterile handle can be securely attached tothe body).

In certain embodiments, the robotic surgical system includes the handlesupport member, wherein the support member is attached to the body.

In certain embodiments, the universal surgical guide comprises: thenavigation marker attached to the body (e.g., the navigation markercomprising a plurality of navigation marker elements wherein theplurality of navigation marker elements are used to triangulate aposition of the universal surgical instrument guide).

In certain embodiments, robotic surgical system includes a drill guide,the drill guide comprising: a proximal portion comprising: a firstexterior surface that is substantially in contact with the interiorsurface of the second channel when the drill guide is accommodatedtherethrough, a second exterior surface comprising threads that engagethe threads of the threaded portion of the second channel to securelyhold the drill guide when the drill guide is accommodated therethrough,and a collar adjacent to the first exterior surface, wherein a diameterof the collar is larger than a diameter of the first exterior surfacesuch that a distance the drill guide can be threaded through the secondchannel is limited by the collar; and a guiding shaft attached to theproximal portion, wherein the guiding shaft is sized and shaped to guidea drill bit therethrough along an axis defined by the interior surfaceof the second channel to a surgical site.

In certain embodiments, the drill bit is an anti-skiving drill bit.

In certain embodiments, the guiding shaft of the drill guide iscylindrical.

In certain embodiments, robotic surgical system includes a master guide,the master guide comprising: a proximal portion comprising: a firstexterior surface that is substantially in contact with the interiorsurface of the second channel when the master guide is accommodatedtherethrough, a second exterior surface comprising threads that engagethe threads of the threaded portion of the second channel to securelyhold the master guide when the master guide is accommodatedtherethrough, and a collar adjacent to the first exterior surface,wherein a diameter of the collar is larger than a diameter of the firstexterior surface such that a distance the master guide may be threadedthrough the second channel is limited by the collar, a guiding shaftattached to the proximal portion, wherein the guiding shaft has aninterior surface having a dimension such that a first surgicalinstrument or second surgical instrument guide can be accommodatedtherethrough along an axis defined by the interior surface of the secondchannel to a surgical site.

In certain embodiments, the guiding shaft of the master guide iscylindrical.

In certain embodiments, the proximal portion of the master guidecomprises: a first channel, and a first opening, wherein a portion ofthe first channel of the master guide adjacent to the first opening isthreaded such that when the second surgical instrument is accommodatedtherethrough, threads of the threaded portion of the first channel ofthe master guide engage threads on the second surgical instrument tosecurely hold the second surgical instrument.

In certain embodiments, robotic surgical system includes a tubulardilator, the tubular dilator comprising: a body with a cross-sectionsuch that the body can be accommodated within and through the guidingshaft of the master guide such that the tubular dilator is constrainedto move only along an axis defined by the guiding shaft of the masterguide, the body comprising: a guiding shaft having an interior surfacehaving a dimension such that a third surgical instrument can beaccommodated therethrough along an axis defined by the interior surfaceof the second channel to a surgical site.

In certain embodiments, the guiding shaft of the tubular dilator iscylindrical.

In certain embodiments, the robotic surgical system includes a roddilator, the rod dilator comprising: a body with a cross-section suchthat the body can be accommodated within and through the guiding shaftof the tubular dilator such that the rod dilator is constrained to moveonly along the axis defined by the guiding shaft of the tubular dilator.

In certain embodiments, the robotic surgical system includes a surgicaltap guide, the surgical tap guide comprising: a proximal portioncomprising: an exterior surface comprising threads that engage thethreads of the threaded portion of the first channel of the master guideto securely hold the surgical tap guide when the surgical tap guide isaccommodated therethrough, and a collar adjacent to the first exteriorsurface, wherein a diameter of the collar is larger than a diameter ofthe exterior surface of the surgical tap guide such that a distance thesurgical tap guide may be threaded through the master guide is limitedby the collar; and one or more stabilizing ends, each of the one or morestabilizing ends having: an exterior surface substantially in contactwith the first channel of the master guide when the tap guide isaccommodated therethrough, and an interior surface sized and shaped toguide a surgical tap along an axis defined by the interior surface ofthe second channel to a surgical site.

In certain embodiments, the each of the one or more stabilizing ends ofthe surgical tap guide is cylindrical.

In certain embodiments, robotic surgical system includes a modifiedsurgical tap, the modified surgical tap comprising: a body having anelongated member with homogeneous diameter; a proximal end comprising ahandle sized and shaped for gripping by a surgeon; and a pointed,threaded distal end.

In certain embodiments, robotic surgical system including a screwextender having a body sized and shaped to be pass through the guidingshaft of the master guide in a manner that is constrained in alldirections except a direction along the axis of the second channel,wherein the screw extender has an interior surface sized and shaped toaccommodate a portion of a screwdriver and a distal end for releasablyholding a surgical screw.

In certain embodiments, robotic surgical system including the surgicalscrew for placing in a bone of a patient, wherein the surgical screw canbe removably attached to the screw extender.

In another aspect, the disclosed technology includes a method of using arobotic surgical system, the method including the steps of: moving amobile cart transporting a robotic surgical system comprising a roboticarm in proximity to an operating table, wherein the robotic arm has anend effector comprising a universal surgical instrument guide attachedthereto, the universal surgical instrument guide arranged to securelyhold a surgical instrument guide and restrict movement of a surgicalinstrument therethrough, wherein the universal surgical instrument guidecomprises: a body comprising: a first channel having an interior surfaceshaped and sized to accommodate a portion of a surgical instrumentguide, wherein the first channel comprises a first opening, wherein aportion of the second channel adjacent to the first opening is threadedsuch that when the surgical instrument guide is inserted in the secondchannel, threads of the threaded portion of the second channel engagethreads on the surgical instrument guide to securely hold the surgicalinstrument guide, and the interior surface of the second channel definesan axis such that, when the surgical instrument guide is inserted intothe universal surgical instrument guide (e.g., when the threads of thethreaded portion of the second channel engage the threads on thesurgical instrument guide), movement of a surgical instrument isconstrained along the axis when the surgical instrument guide is movedwithin the surgical instrument guide, and a navigational marker (e.g.,wherein the navigational marker comprising a plurality of navigationmarker elements wherein the plurality of navigation marker elements areused to triangulate a position of the surgical instrument guide (e.g.,and/or the universal surgical instrument guide)) is attached to theuniversal surgical instrument guide for use by a navigation camera totrack the position of the surgical instrument guide; stabilizing themobile cart; inserting the surgical instrument guide by threading thesurgical instrument guide into the universal surgical instrument guide,wherein the surgical instrument guide comprises: a proximal portioncomprising: a first exterior surface that is substantially in contactwith the interior surface of the first channel when the surgicalinstrument guide is accommodated therethrough, a second exterior surfacecomprising threads that engage the threads of the threaded portion ofthe first channel to securely hold the surgical instrument guide whenthe surgical instrument guide is accommodated therethrough, and a collaradjacent to the first exterior surface, wherein a diameter of the collaris larger than a diameter of the first exterior surface such that adistance the surgical instrument guide may be threaded through the firstchannel is limited by the collar, and a guiding shaft attached to theproximal portion, wherein the guiding shaft has an interior surfacehaving a dimension such that the surgical instrument can be accommodatedtherethrough along an axis defined by the interior surface of the firstchannel to a surgical site; maneuvering the robotic arm to a desiredposition to align the axis defined by the interior surface of the firstchannel of the universal surgical instrument guide (e.g., an axisdefined by the guiding shaft of the surgical instrument guide) at adesired trajectory in relation to the surgical site; limiting movementof the robotic arm to only along the axis defined by the interiorsurface of the first channel; and temporarily fixing the position of therobotic arm (and, therefore, the position of the universal surgicalinstrument guide and the surgical instrument guide).

In certain embodiments, the method includes the steps of: inserting thesurgical instrument through the surgical instrument guide; andmaneuvering the surgical instrument in a manner that is constrained bythe surgical instrument guide.

In certain embodiments, the robotic arm is active and non-backdrivable.

In certain embodiments, the robotic surgical system comprises a forcesensor attached to the robotic arm capable of providing haptic feedbackto a user.

In certain embodiments, the robotic surgical system provides hapticfeedback when the surgical instrument guide contacts bone.

In certain embodiments, the surgical instrument guide is a drill guide.

In certain embodiments, the method includes inserting a drill bitthrough the guide shaft of the drill guide to direct the drill bit tothe surgical site.

In certain embodiments, the drill bit is an anti-skiving drill bit.

In certain embodiments, the method includes the steps of: removing thedrill bit from the guiding shaft of the drill guide; and inserting ak-wire through the guiding shaft of the drill guide.

In certain embodiments, the method includes the steps of: removing thedrill bit from the guiding shaft of the drill guide; removing the drillguide from universal surgical instrument guide; inserting a master guideinto the first channel of the universal surgical instrument guide; andreleasably securing the master guide to the universal surgicalinstrument guide by threading the master guide such that the threads ofthe portion of the first channel engage with threads on an exteriorsurface of the master guide.

In certain embodiments, the master guide comprises: a proximal portioncomprising: a first exterior surface that is substantially in contactwith the interior surface of the second channel when the master guide isaccommodated therethrough, a second exterior surface comprising threadsthat engage the threads of the threaded portion of the second channel tosecurely hold the master guide when the master guide is accommodatedtherethrough, and a collar adjacent to the first exterior surface,wherein a diameter of the collar is larger than a diameter of the firstexterior surface such that a distance the master guide may be threadedthrough the second channel is limited by the collar, a first channel,and a first opening, wherein a portion of the first channel of themaster guide adjacent to the first opening is threaded such that whenthe second surgical instrument is accommodated therethrough, threads ofthe threaded portion of the first channel of the master guide engagethreads on the second surgical instrument to securely hold the secondsurgical instrument; and a guiding shaft (e.g., a cylindrical shaft)attached to the proximal portion, wherein the guiding shaft has aninterior surface having a dimension such that a first surgicalinstrument or second surgical instrument guide can be accommodatedtherethrough along an axis defined by the interior surface of the secondchannel to a surgical site.

In certain embodiments, the method includes the steps of inserting atubular dilator into a guiding shaft of the master guide; and insertinga rod dilator into a guiding shaft of the tubular dilator.

In certain embodiments, the tubular dilator comprises: a body (e.g., acylindrical body) with a cross-section such that the body can beaccommodated within and through the guiding shaft of the master guidesuch that the tubular dilator is constrained to move only along an axisdefined by the guiding shaft of the master guide, the body comprising: aguiding shaft having an interior surface having a dimension such that athird surgical instrument can be accommodated therethrough along an axisdefined by the interior surface of the second channel to a surgicalsite.

In certain embodiments, the method includes the steps of: removing therod dilator from the guiding shaft of the tubular dilator; removing thetubular dilator from the guiding shaft of the master guide; inserting asurgical tap guide into the guiding shaft of the master guide; andreleasably securing the surgical tap guide to the master guide bythreading the surgical tap guide such that threads on an internalsurface of the master guide engage with threads on an exterior surfaceof the surgical tap guide.

In certain embodiments, the surgical tap guide comprises: a proximalportion comprising: an exterior surface comprising threads that engagethe threads of the threaded portion of the first channel of the masterguide to securely hold the surgical tap guide when the surgical tapguide is accommodated therethrough, and a collar adjacent to the firstexterior surface, wherein a diameter of the collar is larger than adiameter of the exterior surface of the surgical tap guide such that adistance the surgical tap guide may be threaded through the master guideis limited by the collar; and one or more stabilizing ends, each of theone or more stabilizing ends having: an exterior surface substantiallyin contact with the first channel of the master guide when the tap guideis accommodated therethrough, and an interior surface sized and shapedto guide a surgical tap along an axis defined by the interior surface ofthe second channel to a surgical site.

In certain embodiments, the method includes the step of: inserting asurgical tap into the surgical tap guide.

In certain embodiments, the method includes the steps of: removing thesurgical tap from the surgical tap guide; removing the surgical tapguide; and inserting a screw extender and screw into the guiding shaftof the master guide, wherein the screw is releasably held by the screwextender.

In certain embodiments, the method includes the steps of: inserting ascrewdriver into the screw extender, such that the screwdriver is incontact with a head of the screw; and removing the screwdriver.

In certain embodiments, the method includes the step of: moving therobotic arm along the axis defined by the interior surface of the firstchannel such that no portion of the screw extender resides within theguiding shaft of the master guide.

BRIEF DESCRIPTION OF THE DRAWINGS

Drawings are presented herein for illustration purposes, not forlimitation. The foregoing and other objects, aspects, features, andadvantages of the invention will become more apparent and may be betterunderstood by referring to the following description taken inconjunction with the accompanying drawings, in which:

FIG. 1 is an illustration of a robotic surgical system in an operatingroom, according to an illustrative embodiment of the invention;

FIG. 2 shows a universal surgical instrument guide, according to anillustrative embodiment of the invention;

FIG. 3 is an illustration of a sterile handle and tightening sleeve,according to an illustrative embodiment of the invention;

FIGS. 4A and 4B are illustrations of a system for securing an instrumentholder (e.g., a universal surgical instrument guide) on a robotic arm,according to an illustrative embodiment of the invention;

FIG. 4C shows a torque screw appropriate for use in attaching auniversal surgical instrument guide to a robotic arm, according to anillustrative embodiment of the invention;

FIG. 4D shows a torque screw inserted through a threaded bushing that ispress fit into the body of a universal surgical instrument guide forattaching the guide to a robotic arm, according to an illustrativeembodiment of the invention;

FIG. 5 shows a drill guide, according to an illustrative embodiment ofthe invention;

FIG. 6 shows a master guide, according to an illustrative embodiment ofthe invention;

FIG. 7 shows a tubular dilator, according to an illustrative embodimentof the invention;

FIG. 8 shows a rod dilator, according to an illustrative embodiment ofthe invention;

FIG. 9 shows a surgical tap guide, according to an illustrativeembodiment of the invention;

FIG. 10 shows a surgical tap, according to an illustrative embodiment ofthe invention;

FIG. 11 shows a screw with screw extender, according to an illustrativeembodiment of the invention;

FIG. 12A and FIG. 12B show inserting a drill guide into a universalsurgical instrument guide, according to an illustrative embodiment ofthe invention;

FIG. 13A and FIG. 13B show inserting a master guide into a universalsurgical instrument guide, according to an illustrative embodiment ofthe invention;

FIG. 14 show inserting a tubular dilator and rod dilator into a masterguide, according to an illustrative embodiment of the invention;

FIG. 15A and FIG. 15B show inserting a surgical tap guide into a masterguide, according to an illustrative embodiment of the invention;

FIG. 16A and FIG. 16B show inserting a tap into a surgical tap guide,according to an illustrative embodiment of the invention;

FIG. 17A and FIG. 17B show inserting a screw with releasably attachedscrew extender attached to a surgical screwdriver into a master guide,according to an illustrative embodiment of the invention;

FIG. 18 and FIG. 18B show a coordinate system for defining the locationof a tool center point where the center of terminal aspect of a roboticarm defines the origin of the coordinate system, according to anillustrative embodiment of the invention;

FIG. 19 shows a navigation screen that may be viewed by a surgeon orsurgical staff during a spinal procedure in order to visualize theposition, orientation, and trajectory of a surgical instrument guiderelative to a patient's anatomy, according to an illustrative embodimentof the invention;

FIG. 20 is a block diagram of a method for performing surgery using auniversal surgical instrument system, according to an illustrativeembodiment of the invention; and

FIGS. 21-52 are illustrations of a patient's anatomy and a surgicalrobotic system during a method of performing a surgical procedure on thepatient's spine using the robotic surgical system with a universalsurgical instrument system attached thereto, according to anillustrative embodiment of the invention.

DETAILED DESCRIPTION

It is contemplated that systems, devices, methods, and processes of theclaimed invention encompass variations and adaptations developed usinginformation from the embodiments described herein. Adaptation and/ormodification of the systems, devices, methods, and processes describedherein may be performed by those of ordinary skill in the relevant art.

Throughout the description, where articles, devices, and systems aredescribed as having, including, or comprising specific components, orwhere processes and methods are described as having, including, orcomprising specific steps, it is contemplated that, additionally, thereare articles, devices, and systems of the present invention that consistessentially of, or consist of, the recited components, and that thereare processes and methods according to the present invention thatconsist essentially of, or consist of, the recited processing steps.

It should be understood that the order of steps or order for performingcertain action is immaterial so long as the invention remains operable.Moreover, two or more steps or actions may be conducted simultaneously.

The mention herein of any publication, for example, in the Backgroundsection, is not an admission that the publication serves as prior artwith respect to any of the claims presented herein. The Backgroundsection is presented for purposes of clarity and is not meant as adescription of prior art with respect to any claim. Headers are providedfor the convenience of the reader and are not intended to be limitingwith respect to the claimed subject matter.

FIG. 1 illustrates an example robotic surgical system in an operatingroom 100. In some implementations, one or more surgeons, surgicalassistants, surgical technologists and/or other technicians, (106 a-c)perform an operation on a patient 104 using a robotic-assisted surgicalsystem. In the operating room the surgeon may be guided by the roboticsystem to accurately execute an operation. This may be achieved byrobotic guidance of the surgical tools, including ensuring the propertrajectory of the tool (e.g., drill or screw). In some implementations,the surgeon defines the trajectory intra-operatively with little or nopre-operative planning. The system allows a surgeon to physicallymanipulate the tool holder to safely achieve proper alignment of thetool for performing crucial steps of the surgical procedure. Operationof the robot arm by the surgeon (or other operator) in force controlmode permits movement of the tool in a measured, even manner thatdisregards accidental, minor movements of the surgeon. The surgeon movesthe tool holder to achieve proper trajectory of the tool (e.g., a drillor screw) prior to operation or insertion of the tool into the patient.Once the robotic arm is in the desired position, the arm is fixed tomaintain the desired trajectory. The tool holder serves as a stable,secure guide through which a tool may be moved through or slid at anaccurate angle. Thus, the disclosed technology provides the surgeon withreliable instruments and techniques to successfully perform his/hersurgery.

In some embodiments, the operation may be spinal surgery, such as adiscectomy, a foraminotomy, a laminectomy, or a spinal fusion. In someimplementations, the surgical robotic system includes a surgical robot102 on a mobile cart. The surgical robot 102 may be positioned inproximity to an operating table 112 without being attached to theoperating table, thereby providing maximum operating area and mobilityto surgeons around the operating table and reducing clutter on theoperating table. In alternative embodiments, the surgical robot (orcart) is securable to the operating table. In certain embodiments, boththe operating table and the cart are secured to a common base to preventany movement of the cart or table in relation to each other, even in theevent of an earth tremor.

The mobile cart may permit a user (operator) 106 a, such as atechnician, nurse, surgeon, or any other medical personnel in theoperating room, to move the surgical robot 102 to different locationsbefore, during, and/or after a surgical procedure. The mobile cartenables the surgical robot 102 to be easily transported into and out ofthe operating room 100. For example, a user 106 a may move the surgicalrobot into the operating room from a storage location. In someimplementations, the mobile cart may include wheels, a track system,such as a continuous track propulsion system, or other similar mobilitysystems for translocation of the cart. The mobile cart may include anattached or embedded handle for locomotion of the mobile cart by anoperator.

For safety reasons, the mobile cart may be provided with a stabilizationsystem that may be used during a surgical procedure performed with asurgical robot. The stabilization system increases the global stiffnessof the mobile cart relative to the floor in order to ensure the accuracyof the surgical procedure. In some implementations, the wheels include alocking system that prevents the cart from moving. The stabilizing,braking, and/or locking system may be activated when the machine isturned on. In some implementations, the mobile cart includes multiplestabilizing, braking, and/or locking systems. In some implementations,the stabilizing system is electro-mechanical with electronic activation.The stabilizing, braking, and/or locking system(s) may be entirelymechanical. The stabilizing, braking, and/or locking system(s) may beelectronically activated and deactivated.

In some implementations, the surgical robot 102 includes a robotic armmounted on a mobile cart. An actuator may move the robotic arm. Therobotic arm may include a force control end-effector configured to holda surgical tool. The robot may be configured to control and/or allowpositioning and/or movement of the end-effector with at least fourdegrees of freedom (e.g., six degrees of freedom, three translations andthree rotations).

In some implementations, the robotic arm is configured to releasablyhold a surgical tool, allowing the surgical tool to be removed andreplaced with a second surgical tool. The system may allow the surgicaltools to be swapped without re-registration, or with automatic orsemi-automatic re-registration of the position of the end-effector.

In some implementations, the surgical system includes a surgical robot102, a tracking detector 108 that captures the position of the patientand different components of the surgical robot 102, and a display screen110 that displays, for example, real time patient data and/or real timesurgical robot trajectories.

In some implementations, a tracking detector 108 monitors the locationof patient 104 and the surgical robot 102. The tracking detector may bea camera, a video camera, an infrared detector, field generator andsensors for electro-magnetic tracking or any other motion detectingapparatus. In some implementation, based on the patient and robotposition, the display screen displays a projected trajectory and/or aproposed trajectory for the robotic arm of robot 102 from its currentlocation to a patient operation site. By continuously monitoring thepatient and robotic arm positions, using tracking detector 108, thesurgical system can calculate updated trajectories and visually displaythese trajectories on display screen 110 to inform and guide surgeonsand/or technicians in the operating room using the surgical robot. Inaddition, in certain embodiments, the surgical robot 102 may also changeits position and automatically position itself based on trajectoriescalculated from the real time patient and robotic arm positions capturedusing the tracking detector 108. For instance, the trajectory of theend-effector can be automatically adjusted in real time to account formovement of the vertebrae or other part of the patient during thesurgical procedure.

FIG. 2 shows a universal surgical instrument guide 200 for attachment toa robotic surgical system. Universal surgical instrument guide attachesto a proximal end of a robotic surgical system with high precision andrigidity using pins 225 a-c (pin 225 c not shown in FIG. 2) and threadedscrew 220. Threaded screw 220 is accessed through first channel 250. Theattachment system is described in greater detail below. Second channel230 is sized for surgical instrument guides to be received therethroughsuch that a portion of the surgical instrument guides resides in thesecond channel 230. Additionally, second channel 230 has a threadedportion 232 near one of its openings such that surgical instrumentguides can engage the threaded portion 232 to be securely held while inuse. The distal end of the threaded portion 232 of second channel 230has a lip 236 to eliminate the possibility of over-threading a surgicalinstrument guide. Alternative temporary secure attachment means may beused with the second channel 230 such as tension sleeves, pressureconnections, quick connect type fittings, or similar. In someembodiments, surgical instruments are inserted directly through thesecond channel 230 of a universal surgical instrument guide without theuse of an additional surgical instrument guide. In those embodiments,surgical instruments may be appropriately threaded as to engage threadsin the second channel 230 of the body of a universal surgical instrumentguide. First channel 250 is shown to be oriented perpendicular to secondchannel 230. In some embodiments of a universal surgical instrumentguide, the first channel 250 and second channel 230 are non-parallel andnot perpendicularly oriented.

FIGS. 4A-B are illustrations of a system for securing universal surgicalinstrument guide body 412 on robotic arm 408. Such an illustrativeattachment system may be used with universal surgical instrument guidesas disclosed herein. In some implementations, the universal surgicalinstrument guide needs to be sterilized (e.g., in autoclave) prior toattachment. The disclosed universal surgical instrument guide may beeasily installed and removed from the robotic system withoutdeteriorating localization precision as well as attachment rigidity.Localization precision may be achieved by, for example, by threelocalization pins 402 extending from the body. A different number oflocalization pins 402 may be used (e.g., 1 to 5 pins). The pins 402 maycome in contact with oblong openings 404 in a thin localization plate406 precisely held on the robotic arm 408 (e.g., held on a base of therobotic arm 410). The universal guide's body 412 may be localized on therobotic arm 408 (e.g., held on a base of the robotic arm 410) using pins402 that come in contact with oblong openings 404 in a localizationplate 406 precisely held on the robot 408. A screw 414 may be tighteneddirectly into the robot 408 to rigidly attached the universal guide'sbody 412 to the robot 408. FIG. 4B illustrates a front view of anexample localization plate 406. The one or more pins 402 may extend fromthe body such that the one or more pins 402, upon mechanically couplingthe body to the robotic arm, engage one or more openings 404 in arobotic arm 408 (e.g., in a localization plate 406 of the robotic arm408) thereby precisely locating the surgical instrument holder relativeto the robotic arm 408 (e.g., the one or more openings 404 may be widerthan the one or more pins and the one or more openings may taper longtheir lengths).

In certain embodiments, the body of a universal surgical instrumentguide comprises a threaded bushing having a threaded interior surfacefor receiving a torque screw therethrough. The first channel of theuniversal surgical instrument guide passes through the interior surfaceof the threaded bushing. The interior surface of the threaded bushing isthreaded such that the threads on the torque screw engage the threads onthe threaded bushing as the tightening screw is inserted through thethreaded bushing. The torque screw is received by a threaded opening inthe localization plate of the robotic arm such that the torque screw maybe tightened to securely attach the universal surgical instrument guideto the robotic arm.

FIG. 4C shows torque screw 414 with threaded portion 440 and smooth stem430. FIG. 4D shows torque screw 414 inserted into threaded bushing 450.In some implementations, a threaded bushing 450 is press fitted intouniversal surgical instrument guide body 412. Torque screw 414 is madeof metal such that it provides a strong attachment to the robot andsatisfies cleaning and sterilization requirements. Threaded portion 440of torque screw 414 engages threaded bushing 450 that is press fittedinto universal surgical instrument guide body 450. As torque screw 414is tightened, threaded portion 440 of torque screw 414 passes throughthreaded bushing 450 such that smooth stem 430 closest to the torquescrew head resides in threaded bushing 450 (e.g., somewhat loosely sincethere are no threads on smooth stem 430 and thus a smaller diameter).The advantage here is the torque screw 414 and universal surgicalinstrument guide body 412 can then be mounted on the robot without therisk of losing torque screw 414 during assembly as torque screw 414cannot slide out of threaded bushing 450 without unscrewing torque screw414 from bushing 450. The universal surgical instrument guide in thisexample includes localization pins 402 as described above. Smooth stem430 also provides a gap between the torque screw 414 and bushing 450 forcleaning.

Referring again to FIG. 2, universal surgical instrument guide 200 hassterile handle support member 240. Sterile handle support member 240 isattached to universal surgical instrument guide 200 with fasteners 245a-d (fastener 245 d not shown). Sterile handle support member 240 issized and shaped to accommodate a sterile handle assembly for grippingby a surgeon in order to manipulate the position of the end-effector ofthe robotic surgical system. Sterile handle support member 240 isremovably attached to universal surgical instrument guide 200. Removableattachment can, for example, assist in sterilization of a universalsurgical instrument guide and its handle support member. In someembodiments, robotic surgical systems comprise a manipulator for theend-effector located in an alternative location (i.e., not on theuniversal surgical instrument guide). Removable attachment of the handlesupport member 240 additionally allows the support member 240 to beremoved from the robotic surgical system when it is not necessary as tonot have an unnecessary obstruction on the universal surgical instrumentguide 200.

FIG. 3 shows a sterile handle mounting on a support member (e.g., 240)of a universal instrument guide for use with a robotic surgical system.In some implementations, the sterile handle 302 includes a tighteningsleeve 304 with a hollow tubular structure having a first open end. Insome implementations, the structure of the tightening sleeve 304 definesan axis along which a portion of the support member (e.g., 240) may beinserted into the tightening sleeve 304.

A sterile handle housing 306 may include a hollow tubular structurehaving a first open end. The sterile handle housing 306 structure maydefining an axis along which the tightening sleeve 304 may be insertedinto the sterile handle housing 306.

The tightening sleeve 304 may include two or more openings along alength of the tightening sleeve allowing the tightening sleeve tomechanically flex under tension. In some implementations, the two ormore openings are two or more slots, holes, or perforations.

A tightening nut 312 may be permanently and removably coupled to thesterile handle housing 306. The tightening nut 312 includes a thread onan interior of the tightening nut. The tightening nut 312 is configuredto engage a thread 310 on exterior of the tightening sleeve 304 andthereby tighten the tightening sleeve 304 such that a diameter of aportion of the tightening sleeve decreases and securely holds a portionof a support member 240 inserted into the tightening sleeve 304. Thetightening sleeve 304 includes a wedge 314 that engages a wedge on theinterior of the sterile handle housing 306 as the tightening nut 312 istightened and the threads inside the tightening nut 312 engage thethreads 310 on the tightening sleeve 304 and pull the tightening sleevein the direction of the tightening nut 312. The wedges force thetightening sleeve to flex and increase the friction between the portionof the support member 240 and the tightening sleeve 304 when the sterilehandle 302 is assembled with the portion of the support member 240inserted into the tightening sleeve 304. Thus, tightening the tighteningnut 312 enables the sterile handle to securely hold the universalsurgical instrument guide.

In some implementations, the sterile handle 302 includes an electricalassembly 316. The electrical assembly 316 may include one or more inputdevices 318 for commanding the robotic surgical system. The one or moreinput devices 318 may include two or more buttons 318 a and 318 bconfigured to enable a user to place the robotic surgical system in oneof a rotation mode, a translation mode, or a combined translation androtation mode. In some implementations, upon selection of a first button318 a of the two or more buttons, the robotic surgical system is in therotation mode, upon selection of a second button 318 b of the two ormore buttons, the robotic surgical system is in the translation mode,and upon selection of both the first and second buttons 318 a-b, therobotic surgical system is in the combined translation and rotationmode. In some implementations, the handle 302 and input device(s)thereon (e.g., buttons) can be used for instructing the robotic systemto translate along a line when the translation button is pressed, rotatearound the line if the rotation button is pressed, and/or translate androtate around the line if both buttons are pressed.

The electrical assembly 316 may be directly integrated into the sterilehandle 302. In some implementations, the electrical assembly 316 can bedone separately (e.g., using overmolding on buttons and cable or epoxyresin to form an assembly which is integrated into the handle using arapid locking system).

In some implementations, the sterile handle 302 is ambidextrous. In someimplementations, the sterile handle 302 is configured such that arobotic surgical system may be used on either side of an operating tablewhen the handle 302 is in use. The sterile handle is configured to beattached directly or indirectly to an end-effector of the roboticsurgical system. In some implementations, the robotic surgical system isconfigured to allow robotically-assisted or unassisted positioningand/or movement of the sterile handle by a user with at least sixdegrees of freedom. The six degrees of freedom may be three degrees oftranslations and three degrees of rotations.

The sterile handle 302 may be completely or partially disposable. Forexample, in some implementations, the electrical assembly 316 may bedisposable. All disposable parts may be produced in molded plastic. Insome implementations, reusable parts may be made of either metal orplastic. In some implementations, the entire sterile handle 302 isreusable. Assembly of the sterile handle 302 may be performedpre-operatively. For example, a disposable sterile handle 302 may becompletely assembled in the packaging. In some implementations, thesterile handle 302 may be assembled intra-operatively. In someimplementations, the electrical assembly 316 may be fixed in the handlebefore mounting the sterile handle 302 on the universal surgicalinstrument guide.

The sterile handle 302 may be made of a sterile material or a materialthat may be sterilized. In some implementations, the sterile handle 302may be sterilized using different technologies, such as using EthyleneOxide (EtO), autoclave, radiation, or other sterilization methods.Different components of the sterile handle 302 using differenttechnologies, for example, mechanical assembly in an autoclave,electrical assembly in an EtO. In some implementations, sterilization isachieved by draping. In some implementations, the sterile handlecomprises one or more sensors configured to detect a presence of asurgeon's hand in proximity to the sterile handle. In someimplementations, the one or more sensors include a presence detector 332that is engaged by a surgeon's hand when the surgeon holds the handlesuch that presence of the hand is detected. The presence detector may bea lever-button detector. In some implementations, the presence detector332 includes one or more capacitive or resistive sensors, or acombination thereof.

Referring again to FIG. 2, navigation marker 210 is attached touniversal surgical instrument guide using a fastener inserted into anopening in the body of universal surgical instrument guide 200 sized andshaped to receive such a fastener. Navigation marker 210 can be anynavigation marker suitable for tracking the position of a universalsurgical instrument guide. Navigation marker 210 comprises threenavigation member elements that can be used to triangulating theposition of the universal surgical instrument guide with high precision.In certain embodiments, a navigation marker may have more or lessconstituent navigation member elements (e.g., 2 or 4). In certainembodiments, the position of a navigation marker is tracked using anavigation camera, wherein the navigation camera is part of a roboticsurgical system. In some embodiments, a navigation marker has more orless navigation member elements. Navigation marker 210 is located on theopposite side of universal surgical instrument guide 200 from handlesupport member 240 to reduce the likelihood of the support member, anysterile handle attached thereto, and any part of a surgeon's body nearthe sterile handle during use from interfering with tracking ofnavigation marker 210.

Fasteners used to attach navigation marker 210 or handle support member240 to universal surgical instrument guide body or to attach theuniversal surgical instrument guide body to a robotic arm (i.e.,fastener 220) may be any fastener suitable to securely hold therespective components together. For example, the fastener may be anexpansion fastener, screw, bolt, peg, flange or similar.

FIG. 5 shows a drill guide 500 engineered for use with a universalsurgical instrument guide (e.g., the guide 200 of FIG. 2). Drill guide500 comprises tapered end 510, guiding shaft 520, and a proximal portioncomprising first exterior surface 530, second exterior surface 540, andcollar 550. Guiding shaft 520 is sized such that the hollow internalportion of the shaft is of appropriate size to accommodate the stem of adrill bit. Guiding shaft 520 runs from tapered end 510 to the terminalaspect of the collar such that a drill bit enters drill guide 500 at anopening near collar 550 and exits drill guide 500 at tapered end 510with its movement restricted along an axis along the long dimension ofguiding shaft 520. First exterior surface 530 is substantially incontact with a second channel (e.g., 230) of a universal surgicalinstrument guide when drill guide 500 is inserted therein such thatdrill guide 500 cannot be easily deflected. Furthermore, threads onsecond exterior surface 540 engage threads (e.g., 232) of the universalsurgical instrument guide's second channel such that drill guide 500 issecurely held by the universal surgical instrument guide. Collar 550 canbe gripped by a surgeon to thread drill guide 500 into a universalsurgical instrument guide and additionally acts as a limiter to preventover-threading of drill guide 500.

FIG. 6 shows a master guide 600 engineered for use with a universalsurgical instrument guide (e.g., the guide of FIG. 2). Master guide 600comprises tapered end 610, guiding shaft 620, and a proximal portioncomprising first exterior surface 630, second exterior surface 640, andcollar 650. Guiding shaft 620 is sized such that the hollow internalportion of the shaft is of appropriate size to accommodate additionalsurgical instrument guides (e.g., for use with narrower instruments) aswell as dilators. Guiding shaft 620 runs from tapered end 610 to theterminal aspect of the collar 650 such that a surgical instrument orsurgical instrument guide enters master guide 600 at an opening nearcollar 650 and exits master guide 600 at tapered end 610 with itsmovement restricted along an axis along the long dimension of guidingshaft 620. In some embodiments, a second surgical instrument guide isinserted into guiding shaft 620, wherein the second surgical instrumentis of a length such that the distal end of the second surgicalinstrument guide terminates in substantially the same plane defined bythe terminal aspect of tapered end 610. First exterior surface 630 issubstantially in contact with a second channel (e.g., 230) of auniversal surgical instrument guide when master guide 600 is insertedtherein such that master guide 600 cannot be easily deflected.Furthermore, threads on second exterior surface 640 engage threads ofthe universal surgical instrument guide's second channel (e.g., 230)such that master guide 600 is securely held by the universal surgicalinstrument guide. Collar 650 can be gripped by a surgeon to threadmaster guide 600 into a universal surgical instrument guide andadditionally acts as a limiter to prevent over-threading of master guide600.

FIG. 7 shows a tubular dilator 700 engineered for use with a masterguide (e.g., the master guide of FIG. 6). Tubular dilator 700 comprisestapered end 710, guiding shaft 720, and collar 730. Guiding shaft 720 issized to be accommodated by the hollow internal portion of the guidingshaft of a master guide. Guiding shaft 720 additionally has a hollowinternal portion sized for accommodating the stem of a rod dilatortherein. A surgeon can grip tubular dilator 700 using collar 730.

FIG. 8 shows a rod dilator engineered for use with a tubular dilator(e.g., the tubular dilator of FIG. 7). Rod dilator 800 comprises taperedend 810, rod 820, and collar 830. Rod 820 is sized to be accommodatedwithin the hollow internal portion of the guiding shaft of a tubulardilator. A surgeon can grip rod dilator 800 using collar 830.

FIG. 9 shows a surgical tap guide engineered for use with a master guide(e.g., the guide of FIG. 6). Surgical tap guide 900 comprisesstabilizing ends 910 and 960, shaft 920, and a proximal portioncomprising first exterior surface 930, second exterior surface 940, andcollar 950. Shaft 920 is sized such that the hollow internal portion ofthe shaft is of appropriate size to accommodate the stem of a surgicaltap guide therein. In certain embodiments, the diameter of the hollowinternal portion of the shaft 920 is larger than the diameter of thehollow internal portions of stabilizing ends 910 and 960. In certainembodiments, the hollow internal portions of stabilizing ends 910, 930,and 960 are of appropriate size to accommodate the stem of a surgicaltap therein. Shaft 920 runs from stabilizing end 910 to the terminalaspect of the collar such that a surgical tap enters surgical tap guide900 at an opening near collar 950 and exits surgical tap guide 900 atstabilizing end 910 with its movement restricted along an axis along thelong dimension of shaft 920. In certain embodiments, this movement isrestricted by the hollow internal portions of the stabilizing ends 910and 960, by the hollow internal portions of stabilizing ends 910 and 960and the hollow internal portion of the first exterior surface 930, or bythe hollow internal portions of stabilizing end 910 and the hollowinternal portion of the first exterior surface 930. Stabilizing ends 910and 960 are substantially in contact with the internal surface of theguiding shaft of a master guide when surgical tap guide 900 is insertedtherein such that surgical tap guide 900 cannot be easily deflected.Stabilizing ends 910 and 960 can be of a larger exterior diameter thanthe shaft 920 and/or first exterior surface 930. Threads 942 on secondexterior surface 940 engage threads of the internal surface of the shaftof a master guide such that surgical tap guide 900 is securely held bythe master guide. Collar 950 can be gripped by a surgeon to threadsurgical tap guide 900 into a master guide and additionally acts as alimiter to prevent over-threading of surgical tap guide 900. In someembodiments, a surgical tap guide may be sized to be attached to auniversal surgical instrument guide (i.e., without using a masterguide).

FIG. 10 shows a modified surgical tap engineered for use with a surgicaltap guide (e.g., the surgical tap guide of FIG. 9). In certainembodiments, a standard commercially available surgical tap may bemodified for use with a surgical tap guide described herein (e.g., thesurgical tap guide of FIG. 9). In general, a commercial surgical tap'sshoulder or collar may need to be adapted to be of the appropriatediameter for use with a surgical tap guide. In some embodiments, nomodification of the surgical tap is necessary. Surgical tap 1000comprises tap end 1010, stem 1020, shoulder 1030, locking ring 1040, andgrip 1050. Tap end 1010 is used for creating threads in a hole drilledin bone in order to retain a screw. Shoulder 1030 limits the distancesurgical tap 1000 may be inserted into a surgical tap guide. Stem 1020is sized in length such that when shoulder 1030 limits surgical tap 1000from further insertion by contacting a portion of the surgical tapguide, distal end 1020 a of stem 1020 is flush with the terminal aspectof the surgical tap guide. Locking ring 1040 engages a ratchet thatlimits the modified surgical tap to being driven either in or out from adrilled hole. The surgeon can grip the surgical tap with grip 1050.

FIG. 11 shows a surgical screw with screw extender engineered for usewith a master guide (e.g., the master guide of FIG. 6). Surgical screw1110 is releasably attached to screw extender 1130 at attachment point1120. Screw extender 1130 is sized to be accommodated within the hollowinternal portion of the guiding shaft of a master guide. Screw extender1130 has a hollow structure such that a screwdriver can be accommodatedwithin in order to contact the head of screw 1110 in order to drive itinto the drilled and tapped hole in a patient's bone.

The surgical instruments, surgical instrument guides, and universalsurgical instrument guides described herein are constructed from medicalgrade materials. In certain embodiments, components of the instrumentsand guides described herein that will not come in contact with thepatient are constructed of medical grade plastic. Any plastic should beeasily sterilizable for reuse of the instruments. In some embodiments,the surgical instruments are disposable. Components of the instrumentsand guides described herein that contact the patient are made of metal.For example, they made be made of stainless steel, titanium, tantalum,cobalt-chromium, or alloys thereof. In certain embodiments, allcomponents and aspects of a universal surgical instrument system aremade of or housed with metal.

The surgical instruments and surgical instrument guides described hereinmay be engineered to have a range of cross-sections. In certainembodiments, the second channel of a universal surgical instrument guidehas a circular cross-section and, consequently, surgical instruments andsurgical instrument guides for use therewith have circularcross-sections as well. Surgical instruments and surgical instrumentguides with circular-cross section are substantially cylindrical inshape. In some embodiments, elliptical or other curved cross-sectionsare used. Requirements arising from the type of procedures to beperformed may dictate what shape cross-section is appropriate for aparticular universal surgical instrument system.

FIGS. 18A and 18B are illustrations of a universal surgical instrumentguide attached to a robotic arm with an overlay of a coordinate systemused to define a tool center point (TCP) that facilitates precisepositioning and trajectory planning for surgical instrument guides andsurgical instruments inserted through the universal surgical instrumentguide. Universal surgical instrument guide 1820 is attached indirectlyto robotic arm 1830. Sterile handle (i.e., manipulator) 1810 is mountedon a support member (e.g., 240) of universal surgical instrument guide1820. Surgical instrument guide 1840 is inserted into universal surgicalinstrument guide 1820. Surgical instrument guide 1840 is engineered suchthat when inserted into universal surgical instrument guide 1820, thereis a defined tool center point 1850 with known coordinates relative torobotic arm 1830. The origin of a coordinate system used to define thetool center point may be located at a flange of a robotic arm. It mayadditionally be located at any convenient to define point such as aninterface, joint, or terminal aspect of a component of a roboticsurgical system.

Other surgical instrument guides engineered for use with universalsurgical instrument guide 1820 and surgical instrument guide 1840 willhave terminal ends that end at tool center point 1850. For example, whena master guide is inserted into universal surgical instrument guide1820, another guide such as a surgical tap guide may additionally beinserted into universal surgical instrument guide 1820 by inserting thesurgical tap guide into the previously inserted master guide. Thesurgical tap guide and master guide are engineered such that the distal(relative to the universal surgical instrument guide) end of the guidingshafts of both guides terminates at substantially the same plane,wherein said plane contains the tool center point such that the toolcenter point is located at approximately a center point of the crosssections of the guides. A surgical instrument inserted into one or moreguides inserted into universal surgical instrument guide 1820 will beconstrained in its movement along the axis defined by the long dimensionof guiding shaft of the guides such that the surgical instrument canmove along the axis and exits the guides (e.g., to enter a surgicalsite) at the tool center point.

In certain embodiments, because the TCP is in a constant positionrelative to the robotic arm, regardless of whether a surgical guide orsurgical instrument is being used with the universal surgical instrumentguide, a surgeon can be provided visualization of the orientation,trajectory, and position of an instrument or instrument guide insertedinto the universal surgical instrument guide. A navigation markerattached to universal surgical instrument guide 1820 can be used totrack the position and orientation of the universal surgical instrumentguide to update the position, orientation, and current trajectory basedon manipulation of robotic arm 1830 by a surgeon using sterile handle1810. Additional information provided by patient imaging (e.g., CT data,radio imaging data, or similar) taken pre- or intra-operatively as wellas navigation markers attached to a patient's body may be combined withdata from a navigation marker attached to a universal surgicalinstrument guide and displayed on a screen viewable by the surgeon suchthat the surgeon can see the location of necessary features of thepatient's anatomy and the position, trajectory, and orientation of asurgical instrument or surgical instrument guide relative to saidanatomy. The use of engineered universal surgical instrument systemseliminates the need for navigation markers to be attached to the end ofsurgical guides or tools in order to precisely determine the position,orientation, and trajectory of a surgical instrument guide relative to apatient's anatomy.

FIG. 19 shows an exemplary navigation screen as viewed by a surgeon orsurgical staff during a spinal procedure. Three of the four panels showradio images of the patient's anatomy with an overlay showing theposition of a surgical instrument guide with its tool center pointhighlighted and a line segment emanating from the tool center pointdemonstrating the current trajectory of the surgical instrument guide orany surgical instrument guided therethrough. The fourth panel shows a 3Dreconstruction of the patient's spine with a rendering of the surgicalinstrument guide shown to further acclimate the surgeon and surgicalstaff to the current position, orientation, and trajectory of thesurgical instrument guide. Such a display changes as the position ororientation of the universal surgical instrument guide are updated bymanipulation of the robotic arm by the surgeon. The surgeon may consultthe current projected trajectory, position, or orientation of thesurgical instrument guide relative to the patient's anatomy tointraoperatively adjust the position of the robotic arm to update thetrajectory, position, and/or orientation of surgical instrument guide(and any surgical instrument inserted therethrough).

FIG. 20 is a block diagram of a method for implanting a surgical screwwith a releasable screw extender into a vertebra of a patient. FIGS.21-52 show internal and external views of a patient during the methoddescribed in FIG. 20. Method 2000 involves the use of a universalsurgical instrument system and a robotic surgical system mounted on acart. The surgical procedure results in a screw (with screw extender)being placed in a vertebra of a patient. This procedure may be repeatedseveral times, for example, in order to install a surgical rod forstabilization and alignment of the patient's spine.

In step 2002, the cart holding on which a robotic arm is mounted ismoved into a position in an operating room appropriate for performingthe surgical procedure. A universal surgical instrument guide has beenattached to the robotic arm (e.g., using an attachment system describedherein above). In step 2004, the cart is stabilized after it is movedinto position. In step 2006, a drill guide is inserted into theuniversal surgical instrument guide (see FIGS. 12A-12B for drill guideduring and after insertion).

In step 2008 of method 2000, the surgeon maneuvers the robotic arm ofthe robotic surgical system into a desired position and orientation(i.e., such that a desired trajectory is achieved). In step 2008, thedesired trajectory is one that allows access to the surgical site (i.e.,the patient's vertebra). FIGS. 21 and 22 show two illustrations of adrill guide attached to a robotic arm by a universal surgical instrumentguide oriented to follow a trajectory to a patient's vertebra.Maneuvering may be assisted by a navigation subsystem that uses anavigation marker attached to the universal surgical instrument guide,the tool center point defined for the universal surgical instrumentsystem, and a display that visualizes the position, orientation, andtrajectory of the drill guide relative to the patient's anatomy for thesurgeon. The surgeon manipulates the robotic arm in step 2008 using amanipulator (i.e., sterile handle) having one or more inputs that limitthe motion of the robotic arm. For example, the robotic arm may be ableto move with six degrees of freedom while one input on the manipulatorlimits the motion to only translational degrees of freedom and anotherinput on the manipulator limits the motion to only rotational degrees offreedom. Thus, the position and orientation of the universal surgicalinstrument guide can be independently updated.

In step 2010 of method 2000, the surgeon limits the movement of therobotic arm to an axis defined by the universal surgical instrumentguide and the drill guide (e.g., by the channel of the universal guidethrough which the drill guide is inserted). The surgeon may press abutton or other similar input on the manipulator or robotic arm to entersuch a “trajectory” mode. Trajectory modes allow the surgeon to easilymanipulate the robotic arm along a trajectory while preventing unwantedlateral movements. In this way, a surgeon's applied force cannot causethe orientation or trajectory of a surgical instrument guide to bealtered while in a trajectory mode. Only once the trajectory mode hasbeen exited (i.e., by pressing the button or similar again) can therobotic arm move freely along any trajectory.

In step 2012 of method 2000, the position of the robotic arm (and thus,the drill guide) is temporarily fixed. In certain embodiments, roboticsurgical systems have activation sensors mounted on the manipulator suchthat the position of the robotic arm is fixed whenever the surgeon isnot gripping the manipulator. The robotic arm may thus be temporarilyfixed by releasing the activation sensor.

In step 2014, the surgeon creates an incision in the skin of the patientin order to access the vertebra with surgical instruments and surgicalinstrument guides. In step 2016, the surgeon unfixes the position of therobotic arm to maneuver the drill guide along the defined trajectorythrough the incision to the surgical site. FIGS. 23 and 24 show twoillustrations of the drill guide that has been maneuvered to thesurgical site (the patient's vertebra). The robotic arm being limited inits motion by the engagement of the trajectory mode ensures precisemovement of the drill guide from outside the patient to the patient'svertebra. The surgeon may monitor the progress of the drill guide on thenavigation display. Without a navigation display with a known preciselocation of the guide's tip, the surgeon would not be able to monitorthe trajectory for accuracy during maneuvering in such a percutaneousapproach. The robotic surgical system may comprise a force sensor thatprovides haptic feedback to the surgeon when contact is made with thebone to avoid excess pressure being applied.

In step 2018 of method 2000, a drill bit is inserted through the drillguide and a hole is drilled in the patient's bone. A lip on the internalsurface of the drill guide's guiding shaft may limit the distance thebit can protrude from the guide and thus limit the drilling depth. Incertain embodiments, the drill bit is an anti-skiving drill bit in orderto ensure the intended trajectory is followed during drilling. Skivingalters the alignment of the drilled hole such that it does not alignwith the trajectory of the drill guide. Misalignment of the drilled holemakes subsequent surgical steps difficult to follow withoutcomplication. FIGS. 25 and 26 show a drill bit guided by a drill guidethrough an incision site and to a patient's vertebra for drilling ahole.

In step 2020 of method 2000, the drill guide is removed and the masterguide is inserted into the universal surgical instrument guide. FIGS. 27and 28 show two illustrations of the drill guide removed from thepatient. FIGS. 29 and 30 show two illustrations of the drill guideremoved from the universal surgical instrument guide. FIGS. 31 and 32show two illustrations of a master guide inserted into the universalsurgical instrument guide. Note that the orientation and position of theuniversal surgical instrument guide do not change as the drill guide isremoved and master guide is inserted. FIGS. 13A and 13B show a masterguide being inserted into a universal surgical instrument guide.

In step 2022 of method 2000, a tubular dilator and rod dilator areinserted into the master guide. The distal end of the master guide(i.e., the tool center point) is located near the patient's skin at theincision site. When inserted, the dilators will rest near the patient'sskin until pushed further into the surgical site. FIGS. 33 and 34 showtwo illustrations of a tubular dilator inserted into the master guide.FIGS. 35 and 36 show two illustrations of a rod dilator inserted intothe tubular dilator. FIG. 14 shows a rod dilator inserted in a tubulardilator that has been inserted in a master guide. The surgeon can pushrod dilator down to the surgical site at the patient's vertebra to pushopen the access area around the drilled hole. After pushing the roddilator down, the tubular dilator can be pushed down. The trajectory ofthe rod dilator and tubular dilator are maintained due to theorientation of the master guide's guiding shaft. FIGS. 37 and 38 showtwo illustrations of a rod dilator pushed through an incision to apatient's vertebra. FIGS. 39 and 40 show two illustrations of a tubulardilator pushed through the incision to the patient's vertebra. After thedilators have been pushed to the surgical site, the surgeon can maneuverthe robotic arm along the defined trajectory such that the distal end ofthe master guide's guide shaft resides at the surgical site. FIGS. 41and 42 show two illustrations of a master guide maneuvered through anincision to a patient's vertebra. Once the master guide is maneuvered tothe patient's vertebra, the tubular and rod dilators can be removed.FIGS. 43 and 44 show two illustrations of a master guide located at apatient's vertebra with dilators removed.

In step 2024 of method 2000, a surgical tap guide is inserted into themaster guide and a surgical tap is used to tap the hole drilled earlierin the method. FIGS. 45 and 46 show two illustrations of a surgical tapguide inserted into the master guide (see FIGS. 15A-15B for surgical tapguide during and after insertion). FIGS. 47 and 48 show twoillustrations of a surgical tap inserted into the surgical tap guide(see FIGS. 16A-16B for surgical tap during and after insertion). Becausethe trajectory defined by the universal surgical instrument guide hasnot changed throughout the procedure, the tap will line up with the holedrilled earlier without the use of any temporary implant (e.g., ak-wire). Once the drilled hole has been tapped, the surgical tap can beremoved from the surgical tap guide.

In step 2026 of method 2000, the surgical tap guide is removed from themaster guide and a pedicle screw with releasably attached extender andscrewdriver is inserted in the master guide. The screw will protrudeslightly from the master guide and be aligned with the tapped hole inthe patient's vertebra. FIGS. 49 and 50 show two illustrations of ascrew being implanted in the tapped hole in the patient's vertebra (seeFIGS. 17A-17B for screw, extender, and screwdriver assembly during andafter insertion). The screwdriver is positioned to engage the screw'shead. The screw extender is releasably attached to the screw such thatthe screw extender can be used to assist in additional procedures thatoccur after method 2000. In step 2028, the screw is implanted in thepatient's vertebra by turning the screwdriver. Then, the screw driver isremoved from the pedicle screw with extender assembly.

Finally, method 2000 ends in step 2030, where the robotic arm may bemoved along its trajectory-mode limited axis away from the surgicalsite. The master guide will translate along the length of the screwextender until the master guide is separated from the screw extender.The use of the trajectory mode ensures that the screw extender is notdisturbed during removal of the master guide. FIGS. 51 and 52 show twoillustrations of the robotic arm after it is maneuvered away from thescrew extender. Note that the orientation of the master guide and thescrew extender are the same. Once the robotic arm is free from asurgical implant such that future motion need not disturb the implant,the trajectory mode can be exited and the robotic arm can be maneuveredfreely as desired by the surgeon. The procedure may be complete oradditional screws or other implants may be implanted.

When desired by a surgeon, method 2000 may be modified for use with ak-wire. A surgeon can proceed through the steps of method 2000 throughstep 2018. Then, after the hole has been drilled following a precisetrajectory, the drill bit is removed and a k-wire is placed in thedrilled hole with trajectory guidance from the drill guide. The drillguide may then be removed from the patient by maneuvering along the longaxis of the k-wire until it is separated from the k-wire. The surgicalprocedure can then proceed with use of cannulated surgical instrumentsfollowing methods known in the art. Using a universal surgicalinstrument system to place a k-wire ensures that the k-wire is correctlyimplanted within the drilled hole along the desired orientation, thusreducing complications that may arise from a misplaced or misorientedk-wire.

For some surgeons, it is important to be able to cross-check a drilledtrajectory after drilling the hole. Integrating this function with theuniversal instrument guide disclosed herein can improve confidence of asurgeon. This function can be implemented using a navigated dilatorwhich goes around a K-wire placed just after drilling. Once thetrajectory is verified, the K-wire can be removed and the procedure cancontinue with the master guide as described herein.

Specifically, a surgeon can proceed through the steps of method 2000through step 2018. Then, after the hole has been drilled following aprecise trajectory, the drill bit is removed and a k-wire is placed inthe drilled hole with trajectory guidance from the drill guide. Next,the drill guide is removed from universal surgical instrument guide. Anavigated dilator (e.g., a tube with an internal diameter sufficient toaccommodate the external diameter of a k-wire and navigation membersthat can be tracked and visualized by navigation systems) is insertedalong the k-wire and pushed down to surgical site. In certainembodiments, the navigated dilator can go through the universal surgicalinstrument guide without being guided by it. As soon as navigateddilator is in contact with patient, the drilled trajectory can becross-checked. Thereafter, the navigated dilator is removed fromsurgical site along the k-wire and then the k-wire is removed frompatient. Method 2000 can then continue from step 2020 with insertion ofmaster guide in universal instrument guide.

It is understood that the method described in FIG. 20 is exemplary. Manysurgical procedures require the use of multiple surgical instrumentsfollowing the same (precise) trajectory such that they benefit from theuse of a universal surgical instrument guide (and accompanying universalsurgical instrument system) with a robotic surgical system. Otherorthopedic and non-orthopedic methods are equally adapted to utilize auniversal surgical instrument guide attached to a robotic arm. Othersurgeries contemplated for use with a universal surgical instrumentguide and/or universal surgical instrument system include, but are notlimited to, orthopedic procedures, ENT procedures, and neurosurgicalprocedures. Such procedures may be performed using an open,percutaneous, or MIS approach.

Certain embodiments of the present invention were described above. Itis, however, expressly noted that the present invention is not limitedto those embodiments, but rather the intention is that additions andmodifications to what was expressly described herein are also includedwithin the scope of the invention. Moreover, it is to be understood thatthe features of the various embodiments described herein were notmutually exclusive and can exist in various combinations andpermutations, even if such combinations or permutations were not madeexpress herein, without departing from the spirit and scope of theinvention. In fact, variations, modifications, and other implementationsof what was described herein will occur to those of ordinary skill inthe art without departing from the spirit and the scope of theinvention. As such, the invention is not to be defined only by thepreceding illustrative description.

Having described certain implementations of methods, systems, andapparatus for performing surgery along precise trajectories withoutsurgical instrument realignment it will now become apparent to one ofskill in the art that other implementations incorporating the conceptsof the disclosure may be used. Therefore, the disclosure should not belimited to certain implementations, but rather should be limited only bythe spirit and scope of the following claims.

What is claimed is:
 1. A method of using a robotic surgical system, themethod comprising the steps of: moving a mobile cart transporting arobotic surgical system comprising a robotic arm in proximity to anoperating table, wherein the robotic arm has an end effector comprisinga universal surgical instrument guide attached thereto, the universalsurgical instrument guide arranged to securely hold a surgicalinstrument and restrict movement of surgical tool therethrough, whereinthe universal surgical instrument guide comprises: a body comprising: afirst channel having an interior surface shaped and sized to accommodatea portion of a surgical instrument, and a second channel, a navigationalmarker is attached to the universal surgical instrument guide for use bya navigation camera to track the position of the surgical instrumentguide; stabilizing the mobile cart; inserting the surgical instrumentinto the universal surgical instrument guide, maneuvering the roboticarm to a desired position to align the axis defined by the first channelof the universal surgical instrument guide at a desired trajectory inrelation to the surgical site; limiting movement of the robotic arm toonly along the axis defined by the interior surface of the firstchannel; and temporarily fixing the position of the robotic arm whereinthe surgical instrument is a drill guide, comprising the step of:inserting a drill bit through the guide shaft of the drill guide todirect the drill bit to the surgical site, wherein the drill bit is ananti-skiving drill bit, and comprising the steps of: removing the drillbit from the guiding shaft of the drill guide; and inserting a k-wirethrough the guiding shaft of the drill guide.
 2. The method of claim 1,comprising the steps of: inserting a surgical tool through the surgicalinstrument; and maneuvering the surgical tool in a manner that isconstrained by the surgical instrument.
 3. The method of claim 1,wherein the robotic arm is active and non-backdrivable.
 4. The method ofclaim 1, wherein the robotic surgical system comprises a force sensorattached to the robotic arm capable of providing haptic feedback to auser.
 5. The method of claim 4, wherein the robotic surgical systemprovides haptic feedback when the surgical instrument guide contactsbone.
 6. The method of claim 1, comprising the steps of: removing thedrill bit from the guiding shaft of the drill guide; removing the drillguide from universal surgical instrument guide; inserting a master guideinto the first channel of the universal surgical instrument guide; andreleasably securing the master guide to the universal surgicalinstrument guide by threading the master guide such that the threads ofthe portion of the first channel engage with threads on an exteriorsurface of the master guide.